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By Yu Zhao, Rene Hardee, Randy Horton, Ashley Miller, Michael Iglesias, Roma Williams, and Jaden Maloney | As is typical with legislative language, the language used in Section 3308 of the Food and Drug Omnibus Reform Act (FDORA) can be difficult to understand, with multiple cross-references to existing laws and use of legal terminology that can be cryptic. Here's our interpretation of key passages relevant to post market change controls and implementing a predetermined change control plan (PCCP) for Class II software as a medical device (SaMD) products. |
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| A New Mindset For Combination Product Development | Article | By Asmita Khanolkar, Cambridge Pharma, SMC Ltd. | As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift. |
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| Annex 1 Compliance Guidelines For Biological Indicator Users | Article | By Crystal Hostler, Mesa Laboratories | Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance, whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators. |
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| Tech Talk: Xover Valve Flow Cytometry | Article | The Lee Company | The Lee Company's Xover Valve excels wherever low crossover, low shear, and low internal volume switching is required. The valves are often used to supply sheath fluid, control samples upstream of the flow cell, or introduce cleaners or reagents to the flow stream. |
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| Benefits Of RFID For Medical Device OEMs | White Paper | HID | Examine why OEMs are increasingly turning to integrated RFID to add value to their products in an increasingly crowded marketplace and discover key applications for RFID in the medical device field. |
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